Welcome! We regret to inform you that the Injury Board National News Desk has been discontinued. Feel free to browse around and enjoy our previously published articles, or visit The Injury Blog Network for the latest in personal injury news.

InjuryBoard member attorney Stephen Sheller of Sheller, P.C., filed the first complaint in February 2003. The allegations originated from six former Lilly drug marketing representatives who became whistleblowers.

Lilly perpetrated fraud on the public, says Sheller, while the whistleblowers complained within the company about Lilly’s improper marketing practices. All six were eventually fired or forced to resign.

One sales representative, who is also a pharmacist, also contacted the company hotline regarding the unethical sales practices but got no response.

“They reported what they felt was very wrong and tried to do it first within the company boundaries, but no one was interested in hearing that,” says Jamie Sheller of Sheller P.C.

In order to boost sales, Lilly marketed Zyprexa for numerous off-label uses targeting doctors at nursing homes and assisted-care facilities to convince them to use Zyprexa for behavioral symptoms such as Alzheimer’s disease, depression and dementia, agitation, aggression, hostility, mood and sleep disorders, according to the complaint.

Reps also encouraged doctors to prescribe for off-label use in children with behavioral problems. Side effects include heart failure and pneumonia in the elderly, and weight gain and diabetes in children.

As early as November 1996, the FDA sent Lilly a letter informing the company it found that Zyprexa’s promotional materials and activities were false and misleading and in violation of the Federal Food, Drug, and Cosmetic Act.

In 2000, Eli Lilly expanded the aggressive marketing campaign with a “Viva Zyprexa” campaign with a goal of making Zyprexa an, “everyday agent in primary care.”

Marketing tactics included off-label lectures and audio conferences for physicians with Lilly sales representatives who posed as persons in the audience with questions about Zyprexa’s expanded use

Lilly produced a video called “The Myth of Diabetes” to minimize the connection between Zyprexa and weight gain and diabetes

In the summer of 2003, Lilly management ordered the destruction of sales literature with misleading information, core sales aids, and flip charts

Lilly promoted the oral version of Zyprexa, called Zydis, and claimed it did not have the same weight-gain effects as Zyprexa

Lilly’s sales force informed doctors that 5 milligrams of Zyprexa at 5 p.m., referred to by the sales slogan, “5 at 5” would help elderly patients with behavioral issues and dementia sleep at night

Zyprexa is Lillys top-selling drug with sales of nearly $40 billion since its approval in 1996.

In accompanying statement, Eli Lilly of Indianapolis says it agreed to plead guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act, even though the company disagrees with and does not admit to the civil allegations of promoting the drug for off-label use.

"We deeply regret the past actions covered by the misdemeanor plea," said John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Lilly. "At Lilly we take seriously our responsibilities to abide by all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve. Every day and with every interaction we strive to operate in a responsible and compliant manner. Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct."

Under the agreement, Lilly will pay $800 million in civil fines and over $600 million in criminal penalties. And Lilly has entered into a corporate integrity agreement with the Department of Health and Human Services Office of Inspector General.

The False Claims Act allows private individual to sue companies that knowingly defraud national or state governments.

The six whistleblowers will share in approximately 18 percent of the federal and qualifying states recoveries; though Sheller adds what they did was difficult both personally and professionally.

“I’m hoping whistleblowers will become heroes to emulate rather than becoming pariahs,” she says. #

Eli Lilly should have gotten their hand slapped as hard as possible. I am in the addiction treatment industry and have seen many occasions where the drug Zyprexa has been prescribed for addiction and depression among many other things.

Comments for this article are closed.

About the National News Desk

Our mission is to seek the complete truth and provide a full and fair account of the events and issues that surround personal safety, accident prevention, and injury recovery. We are committed to serving the public with honesty and integrity in these efforts.

Subscribe to Blog Updates

Enter your email address if you would like to receive email notifications when
comments are made on this post.

Who We AreThe Legal Examiner offers both bloggers and readers the opportunity to share their thoughts and opinions on all things law. From news on current legislative efforts to practical guidance on everyday legal issues, The Legal Examiner will have it covered. Learn More